Antifungal by Galentic Pharma (India) Priva Te Limited ANTIFUNGAL cream

Antifungal by

Drug Labeling and Warnings

Antifungal by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Priva Te Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient                       Purpose

Clotrimazole 1.0%                     Antifungal                          

Purpose

• For treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
• For the treatment of superficial skin infections caused by Yeast (Candida Albicans).
• Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
  

Warnings

Do not use:

• Do not use on children under 2 years of age unless directed by a doctor.
• Avoid contact with eyes.
• For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
• For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  

Indications and Usage

• Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a doctor.
• Supervise children in the use of this product.
• For athlete's foot, pay special attention to spaces between toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Dosage and Administration

• Foe athlete's foot and ringworm, use daily for 4 weeks.
• For jock itch, use daily for 2 weeks.If conditions persist longer, consult a doctor.
• This product is not effective on scalp or nails.

Keep Out Of Reach Of Children

KEEP OUT Of REACH Of CHILDREN

INACTIVE INGREDIENTS

Inactive Ingredients: Cetomicrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraben

Principal Display Panel

Galentic Antifungal Cream

Gal Clotrimazole.jpg

INGREDIENTS AND APPEARANCE

ANTIFUNGAL 
antifungal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-004-01	28.25 g in 1 TUBE
2	NDC: 50382-004-02	113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/07/2013

Labeler - Galentic Pharma (India) Priva Te Limited (918531450)